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Completed

NCT Number: NCT00183326

Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence

This study will determine whether trauma-focused cognitive behavioral therapy (TF-CBT) is more effective than child-centered therapy (CCT) in reducing post traumatic stress disorder (PTSD) in children exposed to domestic violence (DV).

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Key information

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Women's Center and Shelter of Greater Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

About this study

Up to 10 million children in the United States are exposed to DV directed at their mothers by intimate partners. DV exposure puts these children at an increased risk for developing behavioral problems, depression, anxiety, and PTSD. While studies targeting PTSD in DV-exposed children are limited, data indicates that TF-CBT is effective in improving PTSD as well as depression, anxiety, and behavioral symptoms. This study will determine the effectiveness of TF-CBT in reducing PTSD and other DV-related psychological symptoms in children from a community DV agency in Pittsburgh, Pennsylvania.

This study will last 8 weeks. Children and their mothers will be randomly assigned to receive 8 weeks of either TF-CBT or CCT. In TF-CBT, patients recall the events of their trauma and try to deal with the emotions that arise. Supportive treatment empowers children to deal with their emotions in general. Both the children and their mothers will complete questionnaires at study entry and at Week 8. Children will also complete self-report scales at study entry and at Week 8. The questionnaires and self-report scales will be used to assess symptoms of PTSD, depression, anxiety, and behavioral problems. Children and their mothers will be contacted 6 and 12 months after study completion for follow-up interviews.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of PTSD related to exposure to DV, defined as their mother having been the victim of intimate partner violence within 1 year prior to study entry
  • Able to read and understand English
  • Parent or guardian able to read and understand English
  • Parent or guardian willing to give informed consent

Exclusion criteria

  • Certain psychiatric disorders which preclude participation in cognitive-based treatment

Treatment and study plan

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

Behavioral

TF-CBT is a psychotherapeutic intervention designed to help children, youth, and their parents overcome the negative effects of traumatic life events. It was developed by integrating cognitive and behavioral interventions with traditional child abuse therapies that focus on enhancement of interpersonal trust and empowerment. It targets PTSD symptoms, which often co-occur with depression and behavioral problems. TF-CBT also targets other issues experienced by those suffering a trauma including poor self-esteem, mood instability, and difficulty trusting others.

Child-centered supportive therapy (CCT)

Behavioral

CCT demonstrates an empathic approach to healing. An environment consisting of empathy, unconditional positive regard and acceptance are key elements in this mode of therapy.

Primary outcomes

  1. PTSD symptoms

    Time frame: Measured before and after treatment and Months 6 and 12 of follow-up

  2. Anxiety

    Time frame: Measured before and after treatment and Months 6 and 12 of follow-up

  3. Depression

    Time frame: Measured before and after treatment and Months 6 and 12 of follow-up

  4. Behavior

    Time frame: Measured before and after treatment and Months 6 and 12 of follow-up

Secondary outcomes

  1. Contact with perpetrator

    Time frame: Measured at every treatment session

Sponsors and collaborators

Lead sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Treating PTSD in Children Exposed to Domestic Violence

Important dates

Study start
2004
Primary completion
2015
Study completion
2015
First posted
Sep 16, 2005
Registry last updated
Jul 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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